www.fdanews.com/articles/203303-sensome-stroke-treatment-gets-breakthrough-device-status
![Breakthrough Status](https://www.fdanews.com/ext/resources/test/Device_Images6/Breakthrough-Status.gif?t=1620169812&width=430)
Sensome Stroke Treatment Gets Breakthrough Device Status
June 24, 2021
Paris-based devicemaker Sensome’s Clotild Smart Guidewire System for ischemic stroke patients has been granted a Breakthrough Device designation by the FDA.
The guidewire system uses an artificial intelligence-powered tissue sensor that gives physicians critical information about the clot that caused the patient’s stroke.
The first-in-human clinical trial of the system is expected to start later this year, according to Sensome’s CEO Franz Bozsak.